Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 11:35 PM
Study NCT ID:
NCT06583733
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well
Sponsor:
University of Vic - Central University of Catalonia
Organization:
Study Overview
Official Title:
On Any Page, Select Quit to Stop Entering Data. Data Entered on Previous Pages Will be Retained: To Complete Data Entry Later, Open the Record From the Home Page
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOKU Bladder
Brief Summary:
KOKU Bladder aims to develop and test an evidence based digital health program with behavior change techniques to improve bladder health of adults aged 50 and over. A novel module embedded in the approved app "Keep-on-Keep-up" (KOKU) will be co-created with end-users, researchers, health professionals, and stakeholders through a participatory and appreciative action and reflection methodology. After a comprehensive literature review and consultation with 4-6 experts, 6 focus groups will be undertaken in Kaunas(Lithuanian), Catalonia (Spain) and Manchester (UK) to co-create the contents of the module. Data will be analyzed using thematic analysis. Gamification and the Honeycomb model for user experience will be followed to achieve an appropriate technological solution that will be tested through a randomized controlled trial with at least 120 individuals. A mixed methods approach (quantitative/qualitative analysis) will be used to assess the feasibility and acceptability of the program. Open data and science, gender and ethical aspects, as well as a risk management plan are considered. A plan for communication, dissemination, exploitation of results will be considered. KOKU Bladder will be highly scalable and will have wide reach and impact. This proposal is in line with EU policy initiatives on Active and Healthy Ageing (bladder health and continence will be promoted), targeting aspects such as eHealth, Innovation and Digital Care Transformation, by supporting users to demand more responsive and integrated care programs for chronic conditions and enhancing self-management strategies, independence and health intelligence.
Detailed Description:
Phase I (month-M1-3): Prepare and submit protocol to Ethics Committee, conduct an updated review of the on eHealth solutions to manage UI using BCTs (e.g. training, education) that have been designed or tested in older adults, and establish contact with the Lithuanian, Spanish and UK participating institutions. Phase1 is dedicated to the management of the project throughout its duration.
Phase II (M2-5): Consultation with 4-6 experts on Badder Health (BH) and/or behavioral interventions. Develop a first iteration of the eHealth method and module.
Conduct an initial online focus group with 10-12 co-creators of UK to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation).
Develop a first iteration of the eHealth method and module (concept development) - by Reason Digital (tech company in Manchester)
Phase III (M6-14): Organize, conduct and analyze 5 more focus group (2 in Lithuania, 1 UK and 2 Spain) with 10-12 co-creators each (community-dwelling people aged 50+ of both genders with different physical conditions and UI, health professionals and stakeholders with different backgrounds) to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Secondment in University of Manchester.
Phase IV (M14-M20): Further develop the eHealth module (concept development) - by Reason Digital (tech company in Manchester)
Phase V (M21-36): Multicenter two-armed feasibility RCT study with at least 120 participants (WP3). Participants will be randomized to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group.
Phase VI: Early and open communication and dissemination (WP4). Analysis of results.
Phase II (M2-5): Consultation with 4-6 experts on Badder Health (BH) and/or behavioral interventions. Develop a first iteration of the eHealth method and module.
Conduct an initial online focus group with 10-12 co-creators of UK to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation).
Develop a first iteration of the eHealth method and module (concept development) - by Reason Digital (tech company in Manchester)
Phase III (M6-14): Organize, conduct and analyze 5 more focus group (2 in Lithuania, 1 UK and 2 Spain) with 10-12 co-creators each (community-dwelling people aged 50+ of both genders with different physical conditions and UI, health professionals and stakeholders with different backgrounds) to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Secondment in University of Manchester.
Phase IV (M14-M20): Further develop the eHealth module (concept development) - by Reason Digital (tech company in Manchester)
Phase V (M21-36): Multicenter two-armed feasibility RCT study with at least 120 participants (WP3). Participants will be randomized to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group.
Phase VI: Early and open communication and dissemination (WP4). Analysis of results.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: